a pilot trial of gi-4000 plus bevacizumab and either folfox or folfiri

Conditions: Colon Cancer

Summary: the purpose of this study is to test the safety of gi-4000 and see what effects (good and bad) it has against cancer over time. this study is also being done to measure the immune response to gi-4000. study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).

subject visits will occur 1-4 weeks prior to initiation of gi-4000, then * in newly diagnosed (group a) patients, at every folfox/folfiri plus bevacizumab visit, bevacizumab and gi-4000 dosing visit, gi-4000 dosing visit and then quarterly after completion of therapy * in patients with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen (group b), at every bevacizumab and gi-4000 dosing visit, gi-4000 dosing visit and then quarterly after completion of therapy group a patients (n=26) will be enrolled into the study prior to the initiation of first line therapy with bevacizumab plus either folfox (n=13) or folfiri (n=13) * subjects will receive 1 40 yeast units (yu) dose of gi-4000 prior to initiation of folfox or folfiri plus bevacizumab, then intercycle doses of gi-4000 will be given 7 days after each cycle while first line therapy is given (up to 8 cycles) * after completion of first line therapy, subjects will enter the maintenance phase in which bevacizumab and gi-4000 will be given concurrently every 2 weeks for as long as therapy can be tolerated or until progression * if a subject discontinues bevacizumab therapy due to intolerance, the subject will continue gi-4000 every 2 weeks until progression, intolerance or withdrawal from the study group b patients (n=26) with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen ) will enter the trial prior to receiving therapy with bevacizumab * subjects will receive 40 yeast unit (yu) gi-4000 concurrently with each bevacizumab dose for as long as therapy can be tolerated or until progression * if a subject discontinues bevacizumab therapy due to intolerance, the subject will continue gi-4000 every 2 weeks until progression, intolerance or withdrawal from the study

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of metastatic colorectal cancer with a ras mutation * measurable or evaluable disease * no prior therapy fore metastatic disease except for group a: \> 6 months since completion of adjuvant therapy and group b: those patients who enroll just after completing bevacizumab plus folfox or folfiri * anticipated survival of at least 6 months * ambulatory with eastern cooperative oncology group (ecog) performance status of 0 or 1 * ability to maintain weight * normal organ and marrow function * women of child-bearing potential and men must agree to avoid pregnancy or fathering a child for the duration of study participation and for 6 months after the final scheduled study visit. * ability to understand and willingness to sign a written informed consent document exclusion criteria: * prior chemotherapy other than that listed in inclusion criteria * receiving any other investigational agent * known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis * history of known hypersensitivity to s. cerevisiae, bevacizumab or any component of folfox or folfiri * concurrent and chronic therapy with corticosteroids or any other immunosuppressive drugs * uncontrolled hypertension, unstable angina, congestive heart failure, peripheral vascular disease, serious cardiac arrythmias requiring medication * history of heart attack or stroke within 6 months before enrollment * history of intra-abdominal abscess, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease * bleeding disorder or coagulopathy * serious non-healing wound, ulcer or bone fracture * major surgical procedure, open biopsy, or traumatic injury within 4 weeks prior to enrollment or anticipation of need for surgery during the study * known active infection with hiv, hepatitis b or c * history of splenectomy * history of crohn's disease or ulcerative colitis * history of organ transplantation * evidence of immunodeficiency or immune suppression * any autoimmune disease * active infection * concurrent malignancy * pregnant or nursing

Keywords: colon cancer metastatic vaccine